About Us - Ethics & Corporate Compliance Program
INTRODUCTION
Endo Pharmaceuticals is committed to establishing and maintaining an effective compliance program in accordance with the
"Compliance Program Guidance for Pharmaceutical Manufacturers," published by the Office of Inspector General, U.S. Department
of Health and Human Services (the "HHS-OIG Guidance"). Our Ethics & Corporate Compliance Program is one of the key
components of our commitment to the highest standards of corporate conduct.
The purpose of our Ethics & Corporate Compliance Program is to prevent and detect violations of law or company policy.
As HHS-OIG calls for in its Guidance, we have tailored our Ethics & Corporate Compliance Program to fit the unique
environment of our company. Moreover, our Ethics & Corporate Compliance Program is dynamic; we regularly review and
enhance our Ethics & Corporate Compliance Program to meet our evolving compliance needs.
To the best of our knowledge, we are in compliance with our Ethics & Corporate Compliance Program as described, meaning
that we have established the elements outlined. Furthermore, based on our good faith understanding of the statutory
requirements, our Ethics & Corporate Compliance Program is compliant with the requirements of California Health & Safety
Code §§ 119400-119402.
OVERVIEW OF ETHICS & CORPORATE COMPLIANCE PROGRAM
1. Leadership and Structure
We have designated an individual to serve as our Vice President, Ethics & Corporate Compliance and we are
committed to ensuring that this individual has the ability to effectuate change within the organization as necessary
and to exercise independent judgment. Our Vice President, Ethics & Corporate Compliance is charged with the
responsibility for developing, operating, and monitoring the Ethics & Corporate Compliance Program. In addition,
Endo has established a Corporate Compliance Committee to advise the Vice President, Ethics & Corporate Compliance
and to assist in the oversight of the Ethics & Corporate Compliance Program.
2. Written Standards
Endo's Code of Conduct is our statement of ethical and compliance principles that guide our daily operations. The
Code of Conduct establishes that we expect management, employees, and agents of the company to act in accordance with law
and applicable company policy. The Code of Conduct articulates our fundamental principles, values, and framework for
action within our organization.
In addition to our Code of Conduct, we have policies and procedures that address various legal and regulatory
requirements that apply to our company. We have specific policies and procedures that address the risk areas
identified in the HHS-OIG Guidance and the requirements of the PhRMA Code on Interactions with Healthcare Professionals.
In accordance with California Health and Safety Code §§ 119400-119402, we have established an annual dollar
limit of $2,500 on food, gifts, and promotional materials that we may provide to individual medical or health care
professionals in California, as defined in the statute.
3. Education and Training
A critical element of our Ethics & Corporate Compliance Program is the education and training of our employees on
their legal and ethical obligations under applicable federal health care program requirements. Accordingly, we conduct
regular education and training sessions with our employees.
4. Internal Lines of Communication
Endo is committed to fostering dialogue between management and employees. Our goal is that all employees, when
seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a
meaningful response and should be able to do so without fear of retribution. To that end, employees are encouraged
to seek advice from their supervisors or the Ethics & Corporate Compliance Department. Employees may also report such
matters anonymously by calling the Compliance Hotline. The substance of every report will be taken seriously and
promptly investigated, and where necessary, Endo will put corrective measures in place.
5. Auditing and Monitoring
Endo's Ethics & Corporate Compliance Program includes efforts to monitor, audit, and evaluate compliance with the
company's compliance policies and procedures. We note that in accordance with the HHS-OIG Guidance, the nature of our
reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of
factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Responding to Potential Violations
Endo's Ethics & Corporate Compliance Program includes clear disciplinary policies that set out the consequences of
violating the law or company policy. Although each situation is considered on a case-by-case basis, we will
consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.
7. Corrective Action Procedures
An Ethics & Corporate Compliance Program increases the likelihood of preventing, or at least identifying
unlawful and unethical behavior. However, HHS-OIG recognizes that even an effective Ethics & Corporate Compliance
Program may not prevent all violations. As such, our Ethics & Corporate Compliance program requires the company to
respond promptly to potential violations of law or company policy, take appropriate disciplinary action, assess
whether the violation is in part due to gaps in our policies, practices, or internal controls, and take action to
prevent future violations.
|
